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A Study of Medication With or Without Psychotherapy for Complicated Grief

NCT01179568 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2017-01-24

Study results available
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Summary

The major goal of this 4-site, double blind, placebo-controlled intervention trial is to assess the efficacy of medication (Citalopram) alone or with psychotherapy (Complicated Grief Therapy) to treat the symptoms of complicated grief.

Conditions

  • Complicated Grief
  • Bereavement

Interventions

DRUG

Citalopram

16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.

BEHAVIORAL

Complicated Grief Treatment

Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

OTHER

Placebo

16 weeks of daily inactive medication. It will be administered in a double-blind fashion.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • American Foundation for Suicide Prevention

    collaborator OTHER

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Katherine Shear, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2015-02-28
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01179568 on ClinicalTrials.gov